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Background:

Maintenance therapy (MT) in NDMM has been increasingly used to prolong duration of response achieved by ASCT. TOURMALINE-MM3 is a phase 3, double-blind, placebo-controlled study, where ixazomib improved PFS, and is the first study to evaluate the impact of MT on HRQoL post ASCT in NDMM (Dimopoulos et al., Lancet 2019;393:253). HRQoL is an important consideration during MT in NDMM patients with minimal disease burden post ASCT (Anderson et al., Leukemia 2008;22:231).

Aims:

Methods:

In TOURMALINE-MM3, NDMM patients post ASCT were randomly assigned in a 3:2 ratio to oral ixazomib or matching placebo. HRQoL was assessed by EORTC QLQ-C30 (overall/subscale score range, 1-100) at screening, the start of every cycle (1-26), end of treatment, every 4 weeks until start of next line of therapy after progression and twice thereafter. MM-specific symptoms were assessed by EORTC QLQ-MY20 (subscale score range, 1-100) at screening, the start of every 3 cycles between cycles 1-25, end of treatment, every 4 weeks until start of next line of therapy after progression and twice thereafter. For both instruments, higher scores for global and functional domains indicate better HRQoL, while higher scores on symptom scales represent higher levels of symptomatology. Change from study entry in subscale scores, defined in terms of 30 four-week intervals, was analyzed using a linear mixed-effects model among patients who reported HRQoL outcomes at study entry and completed at least one post-study entry assessment.

Summary/Conclusion:

In addition to improvements in PFS with ixazomib, HRQoL was maintained during the protocol-defined treatment period in both arms, and active treatment with ixazomib did not have an adverse impact on HRQoL.

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